Guardian Intraoperative Lead, Small

Basic Information

• Brand Name: Guardian Intraoperative Lead, Small
• Primary DI: B13095240
• Version / Model: 9524
• Catalog Number: 9524
• Company Name: Checkpoint Surgical, Inc.
• Labeler DUNS: 832575364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-01
• Public Version: 1
• Public Version Date: 2023-06-09
• Public Version Status: New
• Public Device Record Key: 3c3d120f-def7-41c0-9b1d-3dc9fdbb677d

Device Description

The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETN	Stimulator, Nerve	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35723	Nerve-locating system	An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B13095241	HIBCC	Pouch	1	In Commercial Distribution
Primary	B13095240	HIBCC
Package	B13095242	HIBCC	Sales Carton	1	In Commercial Distribution
Package	B13095243	HIBCC	Shipping Box	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212355	000

Device Sizes

Type	Value	Unit	Text
Width	4	Millimeter